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The AGILTRAC™ .018 Peripheral Dilatation Catheter is intended:

• To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, . infra popliteal, renal arteries); and
• For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis ● fistulae.

The AGILTRAC™ .018 Peripheral Dilatation Catheter is a two-lumen catheter with a balloon near the distal tip. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated, and the injection of contrast and/or medication through the distal tip.
The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

The provided text describes a 510(k) premarket notification for a medical device, the AGILTRAC™ .018 Peripheral Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for a new, AI-powered diagnostic device.

Therefore, many of the requested categories in your prompt are not applicable to this document as it does not describe an AI medical device or a study involving such a device.

However, I can extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no explicit table of acceptance criteria or reported device performance in the context of an AI device. The document focuses on demonstrating substantial equivalence to an existing predicate device based on technological characteristics and performance data from in vitro bench tests and analyses.

2. Sample size used for the test set and the data provenance:

Not applicable. This is not an AI device. The "test set" would refer to the in vitro bench tests, but no sample sizes or data provenance (country, retrospective/prospective) are specified for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not an AI device, and the ground truth for in vitro bench tests would be established through engineering specifications and measurement standards, not expert consensus.

4. Adjudication method for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the in vitro bench tests, the "ground truth" would be the established engineering specifications and measurement standards for balloon dilatation catheters.

8. The sample size for the training set:

Not applicable. This is not an AI device, so there is no training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of what is available: Performance Data

The document states:
"The safety and effectiveness of the AGILTRAC™ .018 Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses."

This indicates that the "study" demonstrating performance was a series of in vitro bench tests. The ultimate "acceptance criteria" were met by showing that the new device's performance in these in vitro tests was substantially equivalent to the predicate device, the OTW VIATRACTM 18 Peripheral Dilatation Catheter, across various technological characteristics (materials, biocompatibility, mode of operation, performance properties, sterilization, and packaging). No specific numerical thresholds or detailed results of these in vitro tests are provided in this summary.

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